Exercise-meal Timing and Postprandial Glucose Control

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Maximizing Postprandial Glycaemic Control: When is the Right Time for Physical Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03730727
• Other study ID #: ERN_18-0942
• Status: Completed
• Phase: N/A
• Start date: October 9, 2017
• Est. completion date: December 8, 2018

Study information

• Verified date: December 2018
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Physical activity helps maintain optimal postprandial blood glucose control. However, there is a lack of clear information regarding the optimal meal-activity timing required to maximize blood glucose control. By using continuous glucose monitoring (CGM), this randomized controlled trial will determine whether implementing a bout of physical activity immediately before, or immediately after, or shortly after a meal is most optimal. This study will also independently examine the effects of three different physical activities: walking, standing, and circuit-exercises. Minimizing the changes in blood glucose following a meal not only reduces the risk of type 2 diabetes but also reduces cardiovascular-related mortality. Therefore, the data produced by this project will have very important implications for informing healthcare policy and physical activity recommendations.

Description:

Healthy volunteers will undergo an informed consent and screening visit to determine their eligibility. Participants who are included will then be assigned to one of the three studies (walking, standing, or circuit-exercises) and then come to the lab on 5 consecutive mornings to undergo a pre-trial visit and 4 experimental trial visits (A, B, C, and D). The order of the experimental trial visits will be randomized in a counter-balanced, cross-over design.

Screening visit: Having read the participant info sheet, a study investigator will discuss the project with the potential participant who will have the chance to ask any questions. Informed consent will be sought and a General Health and Physical Activity Questionnaire will be completed. Body weight, height, resting heart rate, blood pressure, and waist circumference will be measured, and blood measures of glycated hemoglobin, triglycerides, and cholesterol will be taken.

Pre-trials visit: Participants will come to the laboratory to receive an accelerometer physical activity monitor, a continuous glucose monitor, and to complete a physical activity bout (walking, standing, or stair climbing, depending on which study they are enrolled). Over the next 5 consecutive days, participants will be instructed to maintain their normal diet and activity habits, to record their dietary intake, to refrain from vigorous exercise and alcohol, and continue wearing the accelerometer and continuous glucose monitoring devices at all times.

Experimental trial A: Following an 8-10 hour overnight fast, participants will come to the lab and will be given a 500 calorie meal-replacement drink to consume within 10 minutes. They will remain in a seated position for 2 hours and then complete the physical activity bout (30-min walk, 30-min stand, or 10-min circuit-exercises) after which they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.

Experimental trial B: Following an 8-10 hour overnight fast, participants will come to the lab and complete the physical activity bout. Immediately after this they will be given a 500 calorie meal-replacement drink to consume within 10 minutes and will remain in a seated position for 2 hours, after which they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.

Experimental trial C: Following an 8-10 hour overnight fast, participants will come to the lab and will be given a 500 calorie meal-replacement drink to consume within 10 minutes. Immediately after finishing the meal they will complete the physical activity bout and then remain in a seated position until 2-hours has passed since ingesting the meal. After this time they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.

Experimental trial D: Following an 8-10 hour overnight fast, participants will come to the lab and will be given a 500 calorie meal-replacement drink to consume within 10 minutes. Thirty minutes after finishing the meal they will complete the physical activity bout and then remain in a seated position until 2-hours has passed since ingesting the meal. After this time they may leave the lab. Resting and post-activity heart rate and blood pressure will be recorded.

After the final trial, the accelerometer and continuous glucose monitoring devices will be collected and the participant's role in the study will end.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 8, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65 years.

• Body Mass Index 18-30 kg/m2.

• Generally healthy.

Exclusion Criteria:

• Smoking.

• Pregnancy, or planning to become pregnant, or a nursing mother.

• More than 2 kg weight change during the last month.

• Diabetes.

• Evidence of, or being treated for, cancer or infectious/non-infectious chronic hematological, pulmonary, cardiac, hepatic, renal, or gastrointestinal diseases.

• Any contraindication to exercise

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Hyperglycemia
• Hyperglycemia, Postprandial
• Physical Activity

Intervention

Behavioral:
• Physical activity
Physical activity will consist of either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises (10 squats, 10 push-ups, 10 lunges, 10 sit-ups).

Dietary Supplement:
• Meal
Liquid meal replacement shake containing 500 kcal, with 55% kcals from carb, 30% from fat, and 15% from protein.

Locations

Country	Name	City	State
United Kingdom	University of Birmingham	Edgbaston	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial blood glucose concentrations.	Continuous glucose monitoring (CGM; Dexcom G5 Mobile) will be used to measure the change in glucose levels from baseline.	In all trials, postprandial blood glucose concentrations will be measured - the change from baseline (immediately prior to meal ingestion) 2-hours after meal ingestion.
Secondary	Postprandial blood glucose control (mean).	Mean glucose levels will be derived from CGM-measurements.	In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
Secondary	Postprandial blood glucose control (standard deviation).	The standard deviation of glucose levels will be derived from CGM-measurements.	In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).
Secondary	Postprandial blood glucose control.	The mean amplitude of glycemic excursions will be derived from CGM-measurements.	In all trials, postprandial glucose control will be measured between baseline (immediately prior to meal ingestion) and the end of the trial (2-hours after meal ingestion).